← Product Code [LGR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR) · K895827

# INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (K895827)

_Innotron of Oregon, Inc. · LGR · Oct 31, 1989 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K895827

## Device Facts

- **Applicant:** Innotron of Oregon, Inc.
- **Product Code:** [LGR](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR.md)
- **Decision Date:** Oct 31, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3350
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## Regulatory Identification

A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.

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**Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K895827](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/LGR/K895827)

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